POS0817 TOCILIZUMAB IN NEWLY DIAGNOSED GIANT CELL ARTERITIS VERSUS REFRACTORY/RECURRENT GIANT CELL ARTERITIS; MULTICENTER STUDY OF 471 PATIENTS OF CLINICAL PRACTICE
Authors: J. Sanchez-Martin, J. Loricera, C. Moriano, S. Castañeda, J. Narváez, V. Aldasoro, O. Maiz, R. Melero, I. Villa-Blanco, P. Vela-Casasempere, S. Romero-Yuste, J. L. Callejas-Rubio, E. De Miguel, E. Galíndez-Agirregoikoa, F. Sivera, C. Fernández-López, C. Galisteo, I. Ferraz-Amaro, L. Sanchez-Bilbao, M. Calderón-Goercke, J. L. Hernández Hernández, M. A. González-Gay, R. Blanco
Journal: Annals of the Rheumatic Diseases (2022)

Background Tocilizumab (TCZ) is the only biologic drug approved in giant cell arteritis (GCA), based in two clinical trials (CT) (1,2 ). CT included selected patients who may differ from those of clinical practice (CP). A high proportion of GCA patients treated with TCZ in CT had a newly diagnosed GCA, whereas in CP, most of them are refractory/recurrent GCA (3,4 ). Although in CT the efficacy of TCZ seems to be similar in patients with newly diagnosed GCA and in patients with refractory/recurrent GCA, in CP it is not documented. Objectives To compare in CP, the effectiveness and safety of TCZ in newly diagnosed vs refractory/recurrent GCA. Methods Multicentre observational study on 471 GCA patients treated with TCZ. GCA was diagnosed by: a ) ACR criteria, and/or b ) temporal artery biopsy, and/or c ) imaging techniques. A comparative study between patients with newly diagnosed GCA (&lt;6 weeks) and those with refractory/recurrent GCA (&gt;6 weeks) (according to GiACTA study definitions) (2). Sustained remission was based on EULAR definitions (5 ). Results The 471 GCA patients were divided into 2 subgroups: a ) newly diagnosed GCA (n=91) and b ) refractory/recurrent GCA (n=380) (Table 1). Table 1. Main features of patients with newly diagnosed GCA and refractory/recurrent GCA treated with tocilizumab. Newly diagnosed GCA (n=91 ) Refractory/recurrent GCA (n=380 ) p Baseline characteristics at TCZ onset Age(years), mean±SD 74.3±8.5 73.3±9.1 0.35 Sex, female/male (% female) 60/31 (66) 282/98 (74) 0.11 Time from GCA diagnosis to TCZ onset (months), median [IQR] 1 [0.5-1] 10 [4-24] 0.0001 ESR, mm 1st hour, median [IQR] 46 [17.5-80.5] 27 [10-50] 0.02 CRP, mg/dL, median [IQR] 2.1 [0.7-8.5] 1.3 [0.4-2.8] 0.13 Haemoglobin, g/dL, mean±SD 12.3±1.5 12.7±1.5 0.03 Prednisone dose, mg/day, median [IQR] 40 [21.2-50] 15 [10-30] &lt;0.001 Effectiveness and Safety after TCZ onset Follow-up, (months), median [IQR] 15 [6-27.5] 22 [11-37] 0.004 Relevant adverse events, n (% ) 23 (25) 102 (27) 0.54 Relevant adverse events per 100 patients-year 20 15 NS Serious infections, n (% ) 13 (14) 53 (14) 0.49 Serious infections per 100 patients-year 11.2 8 NS MACES, n (% ) 0 (0) 1 (0.3) - MACES per 100 patients-year 0 0.2 - Malignancies n (% ) 2 (2) 3 (0.8) 0.99 Malignancies per 100 patients-year 1.6 0.5 NS Abbreviations: CRP: C-reactive protein;ESR: erythrocyte sedimentation rate;GCA: giant cell arteritis; IQR: interquartile range; IV: intravenous; MACEs: major adverse cardiovascular events; NS: non significant; SC: subcutaneous; SD: standard deviation No significant differences were observed between both groups in sustained remission, although a greater tendency towards sustained remission is observed in newly diagnosed than in refractory/recurrent GCA patients (Figure 1 ). The decrease in glucocorticoids dose was faster in the first three months in the newly diagnosed GCA group, but thereafter, was similar in both groups, as well as the appearance of relevant adverse events and serious infections. Figure 1. A) Sustained remission, and B) median prednisone dose required in patients with newly diagnosed GCA and in patients with refractory/recurrent GCA treated with tocilizumab. Conclusion The effectiveness and safety of TCZ seems to be similar in patients with newly diagnosed GCA and in patients with refractory/recurrent GCA. References [1]Villiger PM, et al. Lancet. 2016; 387:1921-1927. PMID: 26952547 [2]Stone JH, et al. N Engl J Med. 2017; 377:317-328. PMID: 28745999 [3]Calderón-Goercke M, et al. Semin Arthritis Rheum. 2019; 49: 126-135. PMID: 30655091 [4]Calderón-Goercke M, et al. Clin Exp Rheumatol. 2020; 124: S112-119. PMID: 32441643 [5]Hellmich B, et al. Ann Rheum Dis. 2020; 79: 19-30. PMID: 31270110 Acknowledgements Tocilizumab in Giant Cell Arteritis Spanish Collaborative Group: Juan C. González Nieto (H. Gregorio Marañón), Juan R. de Dios (H.U. Araba), Esther Fernández (H. Clínico Universitario Virgen de la Arrixaca), Isabel de la Morena (H. Clínico Universitario de Valencia), Patricia Moya (H. Sant Pau), Roser Solans i Laqué (H. Valle de Hebrón), Eva Pérez Pampín (H.U. de Santiago), José L. Andréu (H.U. Puerta de Hierro), Marcelino Revenga (H. Ramón y Cajal), Juan P. Baldivieso Achá (H. U. de La Princesa), Eztizen Labrador (H. San Pedro), Andrea García-Valle (Complejo Asistencial Universitario de Palencia), Adela Gallego (Complejo Hospitalario Universitario de Badajoz), Carlota Iñíguez (H.U. Lucus Augusti), Cristina Hidalgo (Complejo Asistencial Universitario de Salamanca), Noemí Garrido-Puñal (H. Virgen del Rocío), Ruth López-González (Complejo Hospitalario de Zamora), José A. Román-Ivorra (H.U. y Politécnico La Fe), Sara Manrique (H. Regional de Málaga), Paz Collado (H.U. Severo Ochoa), Enrique Raya (H. San Cecilio), Valvanera Pinillos (H. San Pedro), Francisco Navarro (H. General Universitario de Elche), Alejandro Olivé-Marqués (H. Trías i Pujol), Francisco J. Toyos (H.U. Virgen Macarena), María L. Marena Rojas (H. La Mancha Centro), Antoni Juan Más (H.U. Son Llàtzer), Beatriz Arca (H.U. San Agustín), Carmen Ordás-Calvo (H. Cabueñes), María D. Boquet (H. Arnau de Vilanova), Noelia Álvarez-Rivas (H.U. Lucus Augusti), María L. Velloso-Feijoo (H.U. de Valme), Cristina Campos (H. General Universitario de Valencia), Íñigo Rúa-Figueroa (H. Doctor Negrín), Antonio García (H. Virgen de las Nieves), Carlos Vázquez (H. Miguel Servet), Pau Lluch (H. Mateu Orfila), Carmen Torres (Complejo Asistencial de Ávila), Cristina Luna (H.U. Nuestra Señora de la Candelaria), Elena Becerra (H.U. de Torrevieja), Nagore Fernández-Llanio (H. Arnáu de Vilanova), Arantxa Conesa (H.U. de Castellón), Eva Salgado (Complejo Hospitalario Universitario de Ourense). Disclosure of Interests Julio Sanchez-Martin: None declared, Javier Loricera: None declared, Clara Moriano: None declared, Santos Castañeda: None declared, J. Narváez: None declared, Vicente Aldasoro: None declared, Olga Maiz: None declared, Rafael Melero: None declared, Ignacio Villa-Blanco: None declared, Paloma Vela-Casasempere: None declared, Susana Romero-Yuste: None declared, Jose Luis Callejas-Rubio: None declared, Eugenio de Miguel: None declared, E. Galíndez-Agirregoikoa: None declared, Francisca Sivera: None declared, Carlos Fernández-López: None declared, Carles Galisteo: None declared, Iván Ferraz-Amaro: None declared, Lara Sanchez-Bilbao: None declared, Monica Calderón-Goercke: None declared, Jose Luis Hernández Hernández: None declared, Miguel A González-Gay Speakers bureau: Abbvie, Pfizer, Roche, Sanofi, Lilly, Celgene and MSD, Grant/research support from: Abbvie, MSD, Jansen and Roche, Ricardo Blanco Speakers bureau: Abbvie, Lilly, Pfizer, Roche, Bristol-Myers, Janssen, UCB Pharma and MSD, Grant/research support from: Abbvie, MSD and Roche